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NOT YET RECRUITING
NCT07850635
PHASE1

A Study of Mirdametinib in Infants and Toddlers With Neurofibromatosis Type 1 Associated Plexiform Neurofibromas

Sponsor: SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine the safety, pharmacokinetic (PK), and tolerability of multiple treatment cycles of oral mirdametinib in infants and toddlers (0 to less than \[\<\] 24 months of age) with measurable neurofibromatosis type 1 (NF1) associated plexiform neurofibromas (PNs) that is symptomatic or asymptomatic but in a high-risk location with a high risk of morbidity.

Official title: A Phase 1b, Open-Label Study of Mirdametinib in Infants and Toddlers With Neurofibromatosis Type 1 Associated Plexiform Neurofibromas

Key Details

Gender

All

Age Range

0 Months - 21 Months

Study Type

INTERVENTIONAL

Enrollment

6

Start Date

2026-12-10

Completion Date

2032-10-21

Last Updated

2026-09-30

Healthy Volunteers

No

Interventions

DRUG

Mirdametinib

Mirdametinib dispersible tablet administered orally.

Locations (1)

Research Site

Darmstadt, Germany